The Research Plan of Taiwan Precision Medicine

NCT ID: NCT04849481

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-23

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Non-small-cell lung cancer (NSCLC) is one of the top three most common cancers in Taiwan. Targetable driver mutations in NSCLC are more prevalent in Asian population compared to those in Western population, which offers chances to apply suitable targeted therapies worldwide. For patients who failed to the treatment of tyrosine kinase inhibitors (TKIs), the genetic mutations from next-generation sequencing (NGS) reports can serve as the reference of treatment selection. Moreover, the expression of PD-1/PD-L1 serves as a helpful indicator for the response of immune checkpoint inhibitors (ICIs). On the other hand, patients with wild-type EGFR/ALK mutations and PD-L1-negative NSCLC who received chemotherapy had relative poorer survival than those received suitable targeted therapies and ICIs. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes in above subpopulations, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced NSCLC patients with wild-type EGFR/ALK or with EGFR/ALK mutation after resistant to TKIs for next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of specific NSCLC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials, and to extend the median overall survival.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Development of an integrated database of genetic background from treatment-naïve and TKI-refractory populations, clinical information, and therapeutic outcomes in advanced NSCLC.

1. To enroll 550 patients who fit the criteria of this study in the enrolled period.
2. To perform large-scale NGS analysis for specific populations, to create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and to find novel treatment strategies.
3. To collect tumor sample for NGS testing
4. To record previous therapeutic agents and accompanying treatment response and adverse events

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small-cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Ages 20 and above.
2. Pathological reports showed adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma, and sacromatoid carcinoma.
3. For patients with squamous cell carcinoma, only never smokers and light smokers (less than 10 cigarettes per day) are indicated.
4. For patients with advanced EGFR (-) and ALK (-) adenocarcinoma or other histological types regardless of EGFR/ALK status, treatment-naïve or failure to ≤ two lines of systemic treatment is allowed.
5. For patients with advanced EGFR (+) or ALK (+) adenocarcinoma, failure to ≤ two lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
6. For patients with advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma, failure to ≤ four lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
7. Reacquisition of tumor tissue after the failure of previous systemic treatment
8. Willingness to provide the residual biopsy/operative slides.
9. Life expectancy more than 3 months.
10. Patients fully understand the protocol with the willingness to have regular follow-up.

Exclusion Criteria

1.Inability to cooperate by providing a complete medical history. 2.No available tumor tissues for genetic testing. 3.Undesirable compliance.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nai-Jung Chiang

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Medical Foundation

Chiayi City, , Taiwan

Site Status RECRUITING

Dalin Tzu Chi Hospital

Dalin, , Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation

Kaohsiung City, , Taiwan

Site Status RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Medical University-Shuang Ho Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taoyuan General Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ya-Ling Wu

Role: CONTACT

886-3-7206166 ext. 35119

Nai-Jung Chiang

Role: CONTACT

886-6-7000123 ext. 65148

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yu-Ching Lin, MD

Role: primary

Chun-Liang Lai

Role: primary

Chin-Chou Wang, PhD

Role: primary

Chong, PhD

Role: primary

Te-Chun Hsia, MD

Role: primary

Gee-Chen Chang, PhD

Role: primary

Tsung-Ying Yang, PhD

Role: primary

Wu-Chou Su, PhD

Role: primary

Chih-Hsin Yang, PhD

Role: primary

Kang-Yun Lee, MD

Role: primary

Yung-Hung Luo, PhD

Role: primary

Chih-Hsin U Yang

Role: primary

Shih-Wei Lee, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

T1521

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.